Flex is a leading sketch-to-scale™ solutions company that designs and builds intelligent products for a connected world. With more than 200,000 professionals across 30 countries and a promise to help make the world Live Smarter™, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets. For more information please visit our careers page at www.flex.com.
Industry: Electrical / Electronic Manufacturing
Type: Public Company
Headquarters: 2 Changi South Lane, Singapore, 486123
The Medical Quality Manager (ISO-13485) will be based Guadalajara, Experience working with project management, Develops and initiates standards and methods for inspection, testing and evaluation and Assist with development and implementation of quality audits. Develops, implements and coordinates product assurance program to prevent or eliminate defects in new or existing products
We are looking for someone who demonstrates:
Passionate customer focus
Thoughtful, fast, disciplined execution
Tenacious commitment to continuous improvement
Relentless drive to win
Here is a glimpse of what you’ll do:
Develops and initiates standards and methods for inspection, testing and evaluation.
Devises sampling procedures and designs and develops forms and instructions for recording.
Develops and implements methods for disposition of discrepant material and devises methods to assess cost and responsibility
Writes training material and conducts training sessions on quality control activities.
Supports quality program managers with customer interfaces as necessary on quality related issues.
Initiates corrective action requests as needed and tracks to satisfactory completion.
Assist with development and implementation of quality audits.
Analyzes reports and returned products and recommends corrective action.
Approves product, process and equipment qualifications.
Provides liaison to various regulatory bodies.
Assures data availability and integrity for all quality related data. Consolidates and reports quality results
Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team.
Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
Cooperates with other top management personnel in formulating and establishing company policies, operating procedures and goals.
Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program.
Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.
Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
Interface with customers on technical/quality issues and improvement initiatives.
Responsible for managing customer audits and regulatory/compliance agency audits.
Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards.
Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.
Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry
Here is some of what you’ll need (required):
Knowledge in Quality Systems.
5-7 years of experience as a Quality Engineer
3 years of experience with project management
5 years working on medical industry
Knowledge in ISO-13485
Experience in PQ, OQ and IQ validations
Knowledge with statistical tools
NCMRs and CAPAs management
Here are a few of our preferred experiences:
Requires a Bachelor´s degree or equivalent experience in addition 4 years’ experience.
Ability to apply statistical tools.
Ability to define problems collects data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.
Ability to use the tools, testing, inspection, Electronical tools, office skills.
Ability to read and interpret documents such as safety rules.
Ability to write routine reports and correspondence.
Impacts operations of immediate work group.
Here are a few examples of what you’ll get for the great work you provide:
Life & Medical insurance.
And more benefits
Flex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: email@example.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.
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Flex is a leading Sketch-to-Scale™ solutions company that designs and builds intelligent products for a connected world. With more than 200,000 professionals across 30 countries and a promise to help the world Live smarter, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets.
We believe in a brighter tomorrow and what people can do when our lives are connected. That’s why every day we set out to do one thing–-create a smarter, more connected world. Our focus is developing and empowering talented people to deliver on their potential, providing employees with a healthy, safe and secure workplace.
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